NSCLCEoYLCNCT04640259
Epidemiology of Young Lung Cancer - Survey
An observational study of NSCLC, run by Addario Lung Cancer Medical Institute at 2 sites in United States.
Trial summary
This is a 100% virtual (remote), case-case study to explore potential environmental, lifestyle and genetic factors that may be associated with driver mutations of young lung cancer in the U.S. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Online Survey
- How many people
- 187 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2021to 6 Mar 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A minimum of 250 subjects distributed with at least 50 subjects among the most common driver mutation groups will be enrolled into the study: 1. EGFR (del19 and L858R) - 50 subjects 2. ROS1 - 50 subjects 3. ALK - 50 subjects 4. KRAS - 50 subjects 5. Other Groups: 1. Uncommon activating mutation for which specific targeted therapy exists (RET fusion, NTRK fusion, BRAF V600E, MET Exon14 skipping mutations, other activating EGFR mutations) - 25 subjects 2. Non-targetable other mutations (p53, NF1, ATM, PIK3CA, RB, non-V600E BRAF, NTRK mutation) or no identified mutation. - 25 subjects Subjects with more than one mutation will be included.
Who may be able to join
- Male or female aged 18 years and over; or the age of majority for their residential state at the time of enrollment
- Documentation of primary NSCLC, any stage
- Less than 50 years of age at the time of NSCLC diagnosis
- Documentation of testing by a CLIA certified lab for genomic drivers of lung cancer
- Willingness to undergo all study procedure
- Provision of written informed consent
Who cannot join
- Male or female aged less than 18 years; or less than the age of majority for their residential state
- Greater than or equal to 50 years of age at the time of NSCLC diagnosis
- No documentation of mutation testing
- Unwilling to undergo all study procedures
- Unable or unwilling to provide consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
USC Keck School of Medicine
Los Angeles, California, 90033
Addario Lung Cancer Medical Institute
San Carlos, California, 94070
About this study
Official title: This is a 100% Virtual (Remote) Study (Survey, and Voluntary Blood Donation) to Explore Potential Environmental, Lifestyle and Genetic Factors That May be Associated With Driver Mutations of Young Lung Cancer in the USA.
This is a 100% virtual (remote), case-case study to explore potential environmental, lifestyle and genetic factors that may be associated with driver mutations of young lung cancer in the U.S.
- Conditions
- NSCLC
- Being tested
- Online Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online SurveyOther
Epidemiological Survey (approx 200 questions)
| Study group | Role | What they receive |
|---|---|---|
| EGFR | Not described Receives: Other: Online Survey | |
| ROS1 | Not described Receives: Other: Online Survey | |
| ALK | Not described Receives: Other: Online Survey | |
| KRAS | Not described Receives: Other: Online Survey | |
| NSCLC Other | Not described Receives: Other: Online Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploratory epidemiology correlates
Exploratory correlations between all questionnaire variables (demographic factors, medical history, smoking history, early life exposures (child and mother), residential history, occupational history, menstrual and reproductive history, diet, and physical activity.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start1 Feb 2021
- Primary completion10 Dec 2025
- Study completion6 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 187 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Addario Lung Cancer Medical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jorge Nieva, MD, Principal investigator, University of Southern CaliforniaBarbara Gitlitz, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640259
- Sponsor's protocol ID
- ALCMI-004
- Acronym
- EoYLC
- Status last verified
- Aug 2026
- First submitted
- 18 Nov 2020
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This is a 100% Virtual (Remote) Study (Survey, and Voluntary Blood Donation) to Explore Potential Environmental, Lifestyle and Genetic Factors That May be Associated With Driver Mutations of Young Lung Cancer in the USA.
- ClinicalTrials.gov ID
- NCT04640259
- Acronym / sponsor ID
- EoYLC / ALCMI-004
- Conditions
- NSCLC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Addario Lung Cancer Medical InstituteUniversity, hospital or other
- Collaborators
- University of Southern California, Ohio State University Comprehensive Cancer Center
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 6 Mar 2026 (actual)
- First posted
- 23 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 100% virtual (remote), case-case study to explore potential environmental, lifestyle and genetic factors that may be associated with driver mutations of young lung cancer in the U.S.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 1 Month
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| EGFR | – | Other: Online Survey |
| ROS1 | – | Other: Online Survey |
| ALK | – | Other: Online Survey |
| KRAS | – | Other: Online Survey |
| NSCLC Other | – | Other: Online Survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A minimum of 250 subjects distributed with at least 50 subjects among the most common driver mutation groups will be enrolled into the study: 1. EGFR (del19 and L858R) - 50 subjects 2. ROS1 - 50 subjects 3. ALK - 50 subjects 4. KRAS - 50 subjects 5. Other Groups: 1. Uncommon activating mutation for which specific targeted therapy exists (RET fusion, NTRK fusion, BRAF V600E, MET Exon14 skipping mutations, other activating EGFR mutations) - 25 subjects 2. Non-targetable other mutations (p53, NF1, ATM, PIK3CA, RB, non-V600E BRAF, NTRK mutation) or no identified mutation. - 25 subjects Subjects with more than one mutation will be included.
Key inclusion criteria (6 listed)
- Male or female aged 18 years and over; or the age of majority for their residential state at the time of enrollment
- Documentation of primary NSCLC, any stage
- Less than 50 years of age at the time of NSCLC diagnosis
- Documentation of testing by a CLIA certified lab for genomic drivers of lung cancer
- Willingness to undergo all study procedure
Key exclusion criteria (5 listed)
- Male or female aged less than 18 years; or less than the age of majority for their residential state
- Greater than or equal to 50 years of age at the time of NSCLC diagnosis
- No documentation of mutation testing
- Unwilling to undergo all study procedures
- Unable or unwilling to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online SurveyEpidemiological Survey (approx 200 questions) | Other | ALK, EGFR, KRAS, NSCLC Other, ROS1 |
Primary outcome
Exploratory epidemiology correlates
Time frame: 1 month
Exploratory correlations between all questionnaire variables (demographic factors, medical history, smoking history, early life exposures (child and mother), residential history, occupational history, menstrual and reproductive history, diet, and physical activity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Nieva, MD principal investigator
University of Southern California
Barbara Gitlitz, MD principal investigator
University of Southern California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, run by Addario Lung Cancer Medical Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploratory epidemiology correlates (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.